A Study to Assess the Pharmacokinetics and Food Effect of SR419 in Healthy Subjects

NCT04705077 | Completed Phase 1

• 1 other identifier: SR419-103
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

This will be an open-label, single-site, Phase I study to evaluate the PK, safety, and tolerability of SR419 in healthy volunteers.

Conditions

Healthy

Outcome Measures

Primary Outcomes (6)

• Peak plasma concentration of SR419

  Up to Day 12

• Time of peak plasma concentration of SR419

  Up to Day 12

• Area under the plasma concentration-time curve of SR419

  Up to Day 12

• Apparent total clearance of SR419

  Up to Day 12

• Terminal half-life of SR419

  Up to Day 12

• Accumulation ratio of SR419

  Up to Day 12

Secondary Outcomes (6)

• Peak plasma concentration of SR419 metabolites

  Up to Day 12

• Time of peak plasma concentration of SR419 metabolites

  Up to Day 12

• Area under the plasma concentration-time curve of SR419 metabolites

  Up to Day 12

• Terminal half-life of SR419 metabolites

  Up to Day 12

• Accumulation ratio of SR419 metabolites

  Up to Day 12

Study Arms (2)

Single Dose Treatment

EXPERIMENTAL

Each subject will be assigned to the fixed period sequence. * Period 1: SR419 suspension in the fasted state; * Period 2: SR419 capsule in the fasted state; * Period 3: SR419 capsule in the fed state (high-fat meal).

Drug: SR419

Repeated Dose Treatment

EXPERIMENTAL

Each subject will receive 30 mg of SR419 capsule, once every 8 hours (Q8h), for 5 days.

Drug: SR419

Interventions

SR419 DRUG

2 formulations of SR419, SR419 suspension and SR419 capsule will be used in the study.

Repeated Dose Treatment; Single Dose Treatment

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy males or females who are 18 to 64 years of age inclusive, are eligible.
• Body weight \> 50 kg (110 pounds) and body mass index (BMI) between 18 and 30 kg/m2.
• Male or female subjects must agree to use contraception methods.
• Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form.

You may not qualify if:

• Clinically significant history of central nervous system (CNS) disease.
• Current or chronic history of liver disease or known hepatic or biliary abnormalities
• History of regular alcohol consumption within 6 months of screening defined as: an average weekly intake of \>21 units for males or \>14 units for females. One unit is equivalent to 8 g of alcohol: a half-pint (\~285 mL) of beer, 1 glass (125 mL) of wine or 1 measure (25 mL) of spirits.
• History of significant drug abuse within one year of screening or use of soft drugs (such as marijuana) within 3 months prior to screening or hard drugs (such as cocaine, methamphetamine, crack) within 1 year prior to screening.
• History of sensitivity to any of the components thereof or a history of drug or other allergy that, in the opinion of the Investigator or Medical Monitor, contraindicates participation.
• History of asthma (excluding resolved childhood asthma), anaphylaxis or anaphylactoid reactions, severe allergic responses.
• History of hypercoagulable state or history of thrombosis.
• A positive Hepatitis B surface antigen, Hepatitis C antibody or human immunodeficiency virus (HIV) antibody result.
• A positive urinary cotinine test or history of regular use of tobacco- or nicotine-containing products (more than 4 products per month within 6 months prior to screening) or unwilling to refrain from use of such products from Screening until completion of the final study visit.
• A positive drug/alcohol result.
• The subject has participated in a clinical trial and has received an investigational product within the following time period prior to the first dosing day in the current study: 30 days, 5 half-lives or twice the duration of the biological effect of the investigational product (whichever is longer).
• Unable to refrain from consumption of Seville oranges, grapefruit or grapefruit juice within 7 days prior to the first dose of IMP until the Safety Follow-up visit.
• A positive pregnancy test result.
• Breast-feeding and/or lactating subject.
• Any reason which, in the opinion of the Investigator, would prevent the subject from participating in the study.

Sponsors & Collaborators

• SIMR (Australia) Biotech Pty Ltd.: lead

Study Sites (1)

CMAX Clinical Research

Adelaide, 5000, Australia

Location

Study Officials

• Thomas Polasek

  CMAX Clinical Research

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 8, 2021
• First Posted: January 12, 2021
• Study Start: February 2, 2021
• Primary Completion: March 12, 2021
• Study Completion: March 12, 2021
• Last Updated: March 25, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)